Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System
8 april 2022 uppdaterad av: Prof Evangelos Terpos, National and Kapodistrian University of Athens
Study of the Kinetics of Antibodies Against SARS-CoV-2 and of Cellular Subpopulations of the Immune System in Volunteers Receiving the BNT162b2 Vaccine or Other Approved Vaccine Against SARS-CoV-2
Determination of both the degree and duration of the immunity provided after receiving the BNT162b2 vaccine against SARS-Cov-2.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Detaljerad beskrivning
The purpose of this study is to assess the kinetics of antibodies against SARS-CoV-2 as well as the kinetics of the immune system's cell subpopulations and cytokines associated with the immune system in healthy volunteers receiving the BNT162b2 vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies or any other vaccine authorized and administered by the Ministry of Health.
Immunoassays will be performed at serum collection points before and after vaccination, as set out in this study.
Studietyp
Observationell
Inskrivning (Förväntat)
600
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Ioanna Charitaki
- Telefonnummer: +30 6976156403
- E-post: j.charitaki@gmail.com
Studieorter
-
-
-
Athens, Grekland
- Rekrytering
- Department of Clinical Therapeutics, General Hospital of Athens ALEXANDRA
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Kontakt:
- Evangelos Terpos, MD
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
The admission criteria include both healthy volunteers and all individuals who, according to the instructions of the Greek State are considered eligible to receive the BNT162b2 vaccine.
In particular, the study includes people with hematological malignancies or solid tumors, either receiving treatment or in remission/ follow-up, pursuant to the vaccination instructions of the Ministry of Health.
The study will also include patients with autoimmune diseases who receive or do not receive treatment for their disease.
Patients with diabetes mellitus, hypertension, heart disease, chronic renal failure of all stages (and undergoing dialysis) or other chronic diseases deemed suitable for vaccination, according to the instructions of the Ministry of Health, may also participate in the study.
Beskrivning
Inclusion Criteria:
- Healthy volunteers and all individuals who, according to the instructions of the Greek State are considered eligible to receive the BNT162b2 vaccine
- Age ≥ 18 years old
Exclusion Criteria:
- Serious allergy problems i.e. hospitalization due to a serious allergic reaction (anaphylaxis)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Cohort 1
Approximately 300 volunteers, healthy or with chronic diseases (diabetes mellitus, hypertension, heart disease, CRF, etc.) with no autoimmune disorders.
|
Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies
Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2
|
|
Cohort 2
People with hematological malignancies or solid tumors in various phases of their treatment (under treatment or in remission/ follow-up).
This cohort may include patients with smoldering multiple myeloma (n=50), multiple myeloma (n=140), chronic lymphocytic leukemia (with or without hypoglobulinemia) (n=50), lymphoma (n=80), AL amyloidosis (n=30), patients who receive PARP (n=30), CDK4/6 (n=30), or immune checkpoint inhibitors (n=40), and patients under therapy with Androgen Receptor Targeted Agents (n=50).
|
Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies
Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Neutralizing antibodies against SARS-CoV-2
Tidsram: Day 50 (28 days after the second dose of the vaccine)
|
Primary endpoint of the study is the development of neutralizing antibodies against SARS-CoV-2 on Day 50 28 days after the second dose of the vaccine) in the study populations
|
Day 50 (28 days after the second dose of the vaccine)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Neutralizing antibodies against SARS-CoV-2
Tidsram: Day 1
|
Development of neutralizing antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
Neutralizing antibodies against SARS-CoV-2
Tidsram: Day 8
|
Development of neutralizing antibodies against SARS-CoV-2 on day 8
|
Day 8
|
|
Neutralizing antibodies against SARS-CoV-2
Tidsram: Day 22
|
Development of neutralizing antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Neutralizing antibodies against SARS-CoV-2
Tidsram: Day 36
|
Development of neutralizing antibodies against SARS-CoV-2 on day 36
|
Day 36
|
|
Neutralizing antibodies against SARS-CoV-2
Tidsram: Month 3
|
Development of neutralizing antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine
|
Month 3
|
|
Neutralizing antibodies against SARS-CoV-2
Tidsram: Month 6
|
Development of neutralizing antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine
|
Month 6
|
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Neutralizing antibodies against SARS-CoV-2
Tidsram: Month 9
|
Development of neutralizing antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine
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Month 9
|
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Neutralizing antibodies against SARS-CoV-2
Tidsram: Month 12
|
Development of neutralizing antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine
|
Month 12
|
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Neutralizing antibodies against SARS-CoV-2
Tidsram: Month 18
|
Development of neutralizing antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine
|
Month 18
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsram: Day 1
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsram: Day 8
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 8
|
Day 8
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsram: Day 22
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 22 (before the second dose of the vaccine)
|
Day 22
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsram: Day 36
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Development of anti-S-RBD antibodies against SARS-CoV-2 on day 36
|
Day 36
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsram: Day 50
|
Development of anti-S-RBD antibodies against SARS-CoV-2 on day 50
|
Day 50
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsram: Month 3
|
Development of anti-S-RBD antibodies against SARS-CoV-2 at 3 months post the second dose of the vaccine
|
Month 3
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsram: Month 6
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Development of anti-S-RBD antibodies against SARS-CoV-2 at 6 months post the second dose of the vaccine
|
Month 6
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsram: Month 9
|
Development of anti-S-RBD antibodies against SARS-CoV-2 at 9 months post the second dose of the vaccine
|
Month 9
|
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Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsram: Month 12
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Development of anti-S-RBD antibodies against SARS-CoV-2 at 12 months post the second dose of the vaccine
|
Month 12
|
|
Development of anti-S-RBD antibodies against SARS-CoV-2
Tidsram: Month 18
|
Development of anti-S-RBD antibodies against SARS-CoV-2 at 18 months post the second dose of the vaccine
|
Month 18
|
|
Number of memory B-cells against SARS-CoV-2
Tidsram: Day 1
|
According to antibody responses on day 1
|
Day 1
|
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Number of memory B-cells against SARS-CoV-2
Tidsram: Day 8
|
According to antibody responses on day 8
|
Day 8
|
|
Number of memory B-cells against SARS-CoV-2
Tidsram: Day 22
|
According to antibody responses on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Number of memory B-cells against SARS-CoV-2
Tidsram: Day 36
|
According to antibody responses on day 36
|
Day 36
|
|
Number of memory B-cells against SARS-CoV-2
Tidsram: Day 50
|
According to antibody responses on day 50
|
Day 50
|
|
Number of memory B-cells against SARS-CoV-2
Tidsram: Month 3
|
According to antibody responses at 3 months post the second dose of the vaccine
|
Month 3
|
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Number of memory B-cells against SARS-CoV-2
Tidsram: Month 6
|
According to antibody responses at 6 months post the second dose of the vaccine
|
Month 6
|
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Number of memory B-cells against SARS-CoV-2
Tidsram: Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
|
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Number of memory B-cells against SARS-CoV-2
Tidsram: Month 12
|
According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
|
|
Number of memory B-cells against SARS-CoV-2
Tidsram: Month 18
|
According to antibody responses at 18 months post the second dose of the vaccine
|
Month 18
|
|
Number of memory T-cells against SARS-CoV-2
Tidsram: Day 1
|
According to antibody responses on day 1
|
Day 1
|
|
Number of memory T-cells against SARS-CoV-2
Tidsram: Day 8
|
According to antibody responses on day 8
|
Day 8
|
|
Number of memory T-cells against SARS-CoV-2
Tidsram: Day 22
|
According to antibody responses on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Number of memory T-cells against SARS-CoV-2
Tidsram: Day 36
|
According to antibody responses on day 36
|
Day 36
|
|
Number of memory T-cells against SARS-CoV-2
Tidsram: Day 50
|
According to antibody responses on day 50
|
Day 50
|
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Number of memory T-cells against SARS-CoV-2
Tidsram: Month 3
|
According to antibody responses at 3 months post the second dose of the vaccine
|
Month 3
|
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Number of memory T-cells against SARS-CoV-2
Tidsram: Month 6
|
According to antibody responses at 6 months post the second dose of the vaccine
|
Month 6
|
|
Number of memory T-cells against SARS-CoV-2
Tidsram: Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
|
|
Number of memory T-cells against SARS-CoV-2
Tidsram: Month 12
|
According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
|
|
Number of memory T-cells against SARS-CoV-2
Tidsram: Month 18
|
According to antibody responses at 18 months post the second dose of the vaccine
|
Month 18
|
|
Number of monocytes (CD14+, CD16+)
Tidsram: Day 1
|
According to antibody responses on day 1
|
Day 1
|
|
Number of monocytes (CD14+, CD16+)
Tidsram: Day 8
|
According to antibody responses on day 8
|
Day 8
|
|
Number of monocytes (CD14+, CD16+)
Tidsram: Day 22
|
According to antibody responses on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Number of monocytes (CD14+, CD16+)
Tidsram: Day 36
|
According to antibody responses on day 36
|
Day 36
|
|
Number of monocytes (CD14+, CD16+)
Tidsram: Day 50
|
According to antibody responses on day 50
|
Day 50
|
|
Number of monocytes (CD14+, CD16+)
Tidsram: Month 3
|
According to antibody responses at 3 months post the second dose of the vaccine
|
Month 3
|
|
Number of monocytes (CD14+, CD16+)
Tidsram: Month 6
|
According to antibody responses at 6 months post the second dose of the vaccine
|
Month 6
|
|
Number of monocytes (CD14+, CD16+)
Tidsram: Month 9
|
According to antibody responses at 9 months post the second dose of the vaccine
|
Month 9
|
|
Number of monocytes (CD14+, CD16+)
Tidsram: Month 12
|
According to antibody responses at 12 months post the second dose of the vaccine
|
Month 12
|
|
Number of monocytes (CD14+, CD16+)
Tidsram: Month 18
|
According to antibody responses at 18 months post the second dose of the vaccine
|
Month 18
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsram: Day 1
|
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsram: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsram: Day 22
|
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsram: Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsram: Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsram: Day 50
|
Inflammatory cytokines measurements on day 50
|
Day 50
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsram: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsram: Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsram: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsram: Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
Interleukin 6 (IL-6), Interleukin 3 (IL-3), Interleukin 1b (IL-1b) levels
Tidsram: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
TNF-a levels
Tidsram: Day 1
|
Inflammatory cytokines measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
TNF-a levels
Tidsram: Day 8
|
Inflammatory cytokines measurements on day 8
|
Day 8
|
|
TNF-a levels
Tidsram: Day 22
|
Inflammatory cytokines measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
TNF-a levels
Tidsram: Day 23
|
Inflammatory cytokines measurements on day 23
|
Day 23
|
|
TNF-a levels
Tidsram: Day 36
|
Inflammatory cytokines measurements on day 36
|
Day 36
|
|
TNF-a levels
Tidsram: Day 50
|
Inflammatory cytokines measurements on day 50
|
Day 50
|
|
TNF-a levels
Tidsram: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
TNF-a levels
Tidsram: Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
TNF-a levels
Tidsram: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
TNF-a levels
Tidsram: Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
TNF-a levels
Tidsram: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
|
CRP levels
Tidsram: Day 1
|
CRP blood level measurements on day 1 (before the first dose of the vaccine)
|
Day 1
|
|
CRP levels
Tidsram: Day 8
|
CRP blood level measurements on day 8
|
Day 8
|
|
CRP levels
Tidsram: Day 22
|
CRP blood level measurements on day 22 (before the second dose of the vaccine)
|
Day 22
|
|
CRP levels
Tidsram: Day 23
|
CRP blood level measurements on day 23
|
Day 23
|
|
CRP levels
Tidsram: Day 36
|
CRP blood level measurements on day 36
|
Day 36
|
|
CRP levels
Tidsram: Day 50
|
CRP blood level measurements on day 50
|
Day 50
|
|
CRP levels
Tidsram: Month 3
|
Inflammatory cytokines measurements at 3 months post the second dose of the vaccine
|
Month 3
|
|
CRP levels
Tidsram: Month 6
|
Inflammatory cytokines measurements at 6 months post the second dose of the vaccine
|
Month 6
|
|
CRP levels
Tidsram: Month 9
|
Inflammatory cytokines measurements at 9 months post the second dose of the vaccine
|
Month 9
|
|
CRP levels
Tidsram: Month 12
|
Inflammatory cytokines measurements at 12 months post the second dose of the vaccine
|
Month 12
|
|
CRP levels
Tidsram: Month 18
|
Inflammatory cytokines measurements at 18 months post the second dose of the vaccine
|
Month 18
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Evangelos Terpos, National and Kapodistrian University of Athens
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Dagla I, Iliou A, Benaki D, Gikas E, Mikros E, Bagratuni T, Kastritis E, Dimopoulos MA, Terpos E, Tsarbopoulos A. Plasma Metabolomic Alterations Induced by COVID-19 Vaccination Reveal Putative Biomarkers Reflecting the Immune Response. Cells. 2022 Apr 6;11(7):1241. doi: 10.3390/cells11071241.
- Gavriatopoulou M, Terpos E, Ntanasis-Stathopoulos I, Briasoulis A, Gumeni S, Malandrakis P, Fotiou D, Migkou M, Theodorakakou F, Eleutherakis-Papaiakovou E, Kanellias N, Kastritis E, Trougakos IP, Dimopoulos MA. Poor neutralizing antibody responses in 106 patients with WM after vaccination against SARS-CoV-2: a prospective study. Blood Adv. 2021 Nov 9;5(21):4398-4405. doi: 10.1182/bloodadvances.2021005444.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
4 januari 2021
Primärt slutförande (Förväntat)
1 augusti 2022
Avslutad studie (Förväntat)
1 december 2022
Studieregistreringsdatum
Först inskickad
3 februari 2021
Först inskickad som uppfyllde QC-kriterierna
5 februari 2021
Första postat (Faktisk)
8 februari 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 april 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 april 2022
Senast verifierad
1 april 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Coronavirusinfektioner
- Coronaviridae-infektioner
- Nidovirales infektioner
- RNA-virusinfektioner
- Virussjukdomar
- Infektioner
- Luftvägsinfektioner
- Luftvägssjukdomar
- Neoplasmer
- Lunginflammation, Viral
- Lunginflammation
- Lungsjukdomar
- Neoplasmer efter plats
- Sjukdomsegenskaper
- Hematologiska sjukdomar
- Covid-19
- Hematologiska neoplasmer
- Kronisk sjukdom
Andra studie-ID-nummer
- 900/24-12-2020
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
At the end of the study, the results will be announced in medical conferences or medical journals.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .